我国人凝血因子Ⅷ制品中血管性血友病因子效力分析  

Efficacy analysis of von Willebrand factor in human coagulation factor FⅧ concentrates in China

作　　者：杜晞[1] 马莉[1] 王宗奎[1] 叶生亮[1] 刘凤娟[1] 张容[1] 苏娜[1] 林方昭[1] 曹海军[1] 李长清[1] DU Xi;MA Li;WANG Zongkui;YE Shengliang;LIU Fengjuan;ZHANG Rong;SU Na;LIN Fangzhaoy;CAO Haijun;LI Changqing(Institute of Blood Transfusion,Chinese Academy of Medical Sciences&Chinese Academy of Medical Sciences,Chengdu 610052,China)

机构地区：[1]中国医学科学院北京协和医学院输血研究所,四川成都610052

出　　处：《中国输血杂志》2021年第6期574-578,共5页Chinese Journal of Blood Transfusion

基　　金：国家药品监督管理局血液制品质量控制重点实验室(依托单位:广东省药品检验所)开放课题(项目编号:KF2021008)。

摘　　要：目的获得国内人凝血因子Ⅷ(FⅧ)制品中血管性血友病因子(vWF)的效力信息。方法获得国内7家及国外1家血液制品厂生产的FⅧ制品,检测其中FⅧ和vWF各项指标。结果国内7家FⅧ制品中有2个厂家FⅧ制品中vWF活性损失超过25%;国内不同厂家FⅧ制品中vWF活性与FⅧ活性比值差异较大,P<0.05。C、D、F厂家制品中vWF活性与FⅧ活性比值>1,与国外批准用于治疗vWD的FⅧ制品wilate@相似。而E厂家制品中此比值>0.7且<1,A、B、G厂家制品中此比值<0.5;另外,国内不同厂家FⅧ制品中FⅧ、vWF比活差异较大,P<0.05,且其中FⅧ、vWF比活远低于wilate@。结论国内FⅧ制品中vWF质量与wilate@的差距主要是vWF含量的差距。从各项指标综合考虑国内C、D厂家制品有用于治疗vWD的可能。Objective To obtain the quality information of von Willebrand factor(vWF) in coagulation factor Ⅷ(FⅧ) concentrates in China. Methods FⅧ concentrates produced by 7 domestic blood product manufactures and 1 foreign manufacture were collected, then FⅧ and vWF contained in FⅧ concentrates were evaluated. Results The activity loss of vWF was more than 25% in 2 of the 7 domestic FⅧ concentrates. The ratio of vWF activity to FⅧ activity in FⅧ concentrates from different domestic manufactures was significantly different(P<0.05). The ratio in FⅧ concentrates prepared by C, D, F manufacturer was greater than 1, which was similar to that in willate@ approved abroad for the treatment of vWD. The ratio in FⅧ concentrates prepared by E manufacturer was greater than 0.7 and less than 1, and by A, B, G manufacturers was less than 0.5. In addition, the specific activities of FⅧ and vWF were significantly different among different FⅧ concentrates in China(P<0.05), and the specific activities of FⅧ and vWF were much lower than that of willate@. Conclusion The variation of vWF quality between domestic FⅧ concentrates and willate@ is mainly due to the different in vWF content. After the comprehensive consideration of various indicators, the FⅧ concentrates made by C and D manufacturers may be used in the treatment of vWD.

关 键 词：血管性血友病因子 人凝血因子Ⅷ制品 血管性血友病 vWF多聚体 

分 类 号：R977.8[医药卫生—药品]